CM4 Winner Evo Device With Hammer
CM4 Winner Evo Device WITH HAMMER, electrodes, gel and lead wires
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Grandway Technology (Shenzhen) Limited | Shenzhen | Guangdong | Contract manufacturer | 6 |
| JKH Health Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 22 |
| Shenzhen Dongdixin Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
Record
| Listed by | Drive DeVilbiss Healthcare, United States |
|---|---|
| FDA product code | IMI |
| Device type | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5300 |
| Establishment | Repacker / relabeller |
| Record published | 2019-11-05 |
| Record revised | 2026-05-27 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 410-012-HMR | In distribution |
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| Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 4 |
| Solaris Soundhead | Dynatronics Corp. | 3 |
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| Therasound EVO | Drive DeVilbiss Healthcare | 3 |
| Therasound | Drive DeVilbiss Healthcare | 2 |
| Echo Ultrasound Device (USA) | Thermotek, Inc. | 2 |
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| Echo Ultrasound Device (PRC) | Thermotek, Inc. | 2 |
| Therasound EVO Package | Drive DeVilbiss Healthcare | 2 |
Showing 12 of 44. All products under Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.